insomnia
Conditions
Interventions
Experimental group:Test group:Guipi Anshuiyin Granules, Specification : 17 grams per bag, oral, 2 bags each time, 2 times a day
The control group:Control group:Guipi Anshuiyin granules simulating agent,Specification : 17 grams per bag, oral, 2 bags each time, 2 times a day
Sponsors
Shenzhen Hospital of Beijing University of Chinese Medicine (Longgang)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia in Western medicine; 2. Meet the standard of deficiency syndrome of heart and spleen in traditional Chinese medicine. 3. Be between 20-65 years old (including 20 and 65 years old), regardless of gender; 4. Pittsburgh Sleep Quality Index Scale (PSQI) score >7 points; 5. Have not received insomnia-related treatment 1 week before treatment. 6. Be able to complete various scoring scales independently. 7. Those who voluntarily participate in this trial and sign an informed consent form. 8. Those who have participated in clinical trials of other drugs in the past 1 month; 9. Strictly adhere to the treatment methods prescribed in this study, obey the doctor's arrangement, and be able to cooperate with treatment and follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Secondary insomnia (insomnia related to other mental disorders, sleep disorders due to internal medicine diseases - insomnia type, substance-caused sleep disorders - insomnia type), environmental sleep disorders, etc.; 2. >=17 points for the Hamilton Depression Scale (Annex III) and >=14 points for the Hamilton Anxiety Scale (Annex IV) ; 3. Use any other traditional Chinese medicine and proprietary Chinese medicine or non-drug treatment measures or non-short-acting sedative hypnotic drugs and antidepressants and anti-anxiety drugs within one week to treat insomnia; 4. Have a serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumors or AIDS; 5. Suspected or indeed have a history of alcohol or drug abuse; 6. Those who are unable to cooperate with physical or mental illness (such as blindness, deafness, muteness, intellectual disability, mental disorder, etc.); 7. Those who have participated in clinical trials of other drugs in the past 1 month; 8. Other factors that the investigator or assistant investigator determines are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| infrared thermal imaging examination;fatigue scale-14;hyperarousal scale, HAS;Insomnia severity index, ISI;TCM symptom score; | — |
Countries
China
Contacts
Public ContactHan Zhenyun
Shenzhen Hospital of Beijing university of Chinese medicine
Outcome results
None listed